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Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial.
Diabet Med. 2008 Apr; 25(4):442-9.DM

Abstract

AIMS

This 24-month, multi-national, open-label, parallel group trial investigated the long-term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat-to-target concept.

METHODS

Patients were randomized 2 : 1 to detemir (n = 331) or NPH (n = 166) groups. Basal insulin was initiated once daily (evening) and titrated individually based on self-measured plasma glucose (PG) levels, aiming for pre-breakfast and pre-dinner targets < or = 6.0 mmol/l. A second basal morning dose could be added according to pre-defined criteria.

RESULTS

After 24 months, superiority of glycated haemoglobin (HbA(1c)) was achieved with detemir compared to NPH (detemir 7.36%, NPH 7.58%, mean difference -0.22% points) [95% confidence interval (CI) -0.41 to -0.03%], with reductions of 0.94% and 0.72% points, respectively. Fasting PG (FPG(lab)) was also lower with detemir (detemir 8.35 mmol/l, NPH 9.43 mmol/l; P = 0.019). Twenty-two per cent of patients treated with detemir reached an HbA(1c) < or = 7.0% in the absence of confirmed hypoglycaemia during the last month of treatment vs. 13% on NPH (P = 0.019). Risk of major and nocturnal hypoglycaemia was 69% and 46% lower with detemir than with NPH (P < 0.001), respectively; patients treated with detemir gained less weight (detemir 1.7 kg, NPH 2.7 kg; P = 0.024). The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings.

CONCLUSIONS

Long-term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA(1c), with added benefits of less major and nocturnal hypoglycaemia and less weight gain.

Authors+Show Affiliations

Department of Medicine, University of Queensland, Australia. p.bartley@uq.edu.auNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18387078

Citation

Bartley, P C., et al. "Long-term Efficacy and Safety of Insulin Detemir Compared to Neutral Protamine Hagedorn Insulin in Patients With Type 1 Diabetes Using a Treat-to-target Basal-bolus Regimen With Insulin Aspart at Meals: a 2-year, Randomized, Controlled Trial." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 25, no. 4, 2008, pp. 442-9.
Bartley PC, Bogoev M, Larsen J, et al. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008;25(4):442-9.
Bartley, P. C., Bogoev, M., Larsen, J., & Philotheou, A. (2008). Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabetic Medicine : a Journal of the British Diabetic Association, 25(4), 442-9. https://doi.org/10.1111/j.1464-5491.2007.02407.x
Bartley PC, et al. Long-term Efficacy and Safety of Insulin Detemir Compared to Neutral Protamine Hagedorn Insulin in Patients With Type 1 Diabetes Using a Treat-to-target Basal-bolus Regimen With Insulin Aspart at Meals: a 2-year, Randomized, Controlled Trial. Diabet Med. 2008;25(4):442-9. PubMed PMID: 18387078.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. AU - Bartley,P C, AU - Bogoev,M, AU - Larsen,J, AU - Philotheou,A, PY - 2008/4/5/pubmed PY - 2008/7/17/medline PY - 2008/4/5/entrez SP - 442 EP - 9 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet Med VL - 25 IS - 4 N2 - AIMS: This 24-month, multi-national, open-label, parallel group trial investigated the long-term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat-to-target concept. METHODS: Patients were randomized 2 : 1 to detemir (n = 331) or NPH (n = 166) groups. Basal insulin was initiated once daily (evening) and titrated individually based on self-measured plasma glucose (PG) levels, aiming for pre-breakfast and pre-dinner targets < or = 6.0 mmol/l. A second basal morning dose could be added according to pre-defined criteria. RESULTS: After 24 months, superiority of glycated haemoglobin (HbA(1c)) was achieved with detemir compared to NPH (detemir 7.36%, NPH 7.58%, mean difference -0.22% points) [95% confidence interval (CI) -0.41 to -0.03%], with reductions of 0.94% and 0.72% points, respectively. Fasting PG (FPG(lab)) was also lower with detemir (detemir 8.35 mmol/l, NPH 9.43 mmol/l; P = 0.019). Twenty-two per cent of patients treated with detemir reached an HbA(1c) < or = 7.0% in the absence of confirmed hypoglycaemia during the last month of treatment vs. 13% on NPH (P = 0.019). Risk of major and nocturnal hypoglycaemia was 69% and 46% lower with detemir than with NPH (P < 0.001), respectively; patients treated with detemir gained less weight (detemir 1.7 kg, NPH 2.7 kg; P = 0.024). The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings. CONCLUSIONS: Long-term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA(1c), with added benefits of less major and nocturnal hypoglycaemia and less weight gain. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/18387078/Long_term_efficacy_and_safety_of_insulin_detemir_compared_to_Neutral_Protamine_Hagedorn_insulin_in_patients_with_Type_1_diabetes_using_a_treat_to_target_basal_bolus_regimen_with_insulin_aspart_at_meals:_a_2_year_randomized_controlled_trial_ L2 - https://doi.org/10.1111/j.1464-5491.2007.02407.x DB - PRIME DP - Unbound Medicine ER -